A1C

Biomea Fusion Reports First Quarter 2024 Financial Results and Corporate Highlights

Retrieved on: 
Jeudi, mai 2, 2024

Cash position of $145.3 million at the end of the first quarter of 2024

Key Points: 
  • Cash position of $145.3 million at the end of the first quarter of 2024
    REDWOOD CITY, Calif., May 02, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “the Company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, reported first quarter 2024 financial results and corporate highlights.
  • There is currently a waitlist for the fourth cohort which we expect will open for enrollment in the second half of this year.
  • This is truly an exciting and validating update on our progress in type 1 diabetes.
  • On track to announce a third development candidate from the Biomea FUSION™ Platform technology.

Dario Publishes New Peer-Reviewed Study that Deepens the Body of Evidence that Managing Cardiometabolic Conditions in One Integrated Platform Improves Clinical Outcomes

Retrieved on: 
Jeudi, avril 25, 2024

NEW YORK, April 25, 2024 /PRNewswire/ -- DarioHealth Corp. (Nasdaq: DRIO) ("Dario" or the "Company"), a leader in the global digital health market, announced today new research published in the leading peer-reviewed journal for digital health and medicine, Journal of Internet Medicine (JMIR) demonstrating a clinically significant reduction in blood glucose levels for members using Dario to manage weight alongside diabetes.

Key Points: 
  • Dario's cardiometabolic solution helps people manage related cardiometabolic health needs, including diabetes, pre-diabetes, blood pressure, weight and support for people taking a GLP-1, with a single integrated and highly personalized experience.
  • Dario's solution is designed to help people adopt the healthier behaviors required to support improved clinical outcomes, which includes self-health management behaviors such as monitoring weight and blood glucose.
  • This new retrospective, quasi-randomized study examined the data from 1,932 Dario members over the course of a year.
  • The research was conducted in partnership with Integrative Pain Laboratory, the School of Public Health at the University of Haifa.

Biomea Fusion Highlights Initial Data from the First Two Type 1 Diabetes Patients Dosed with BMF-219

Retrieved on: 
Lundi, avril 1, 2024

REDWOOD CITY, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, today announced initial response data from the first two type 1 diabetes patients treated with BMF-219 in the ongoing Phase II study (COVALENT-112).

Key Points: 
  • “We are very excited to announce the initial response data from the first two type 1 diabetes patients enrolled in the COVALENT-112 study.
  • Both patients showed improvement in measures of beta-cell function after only 4 weeks of dosing with BMF-219.
  • The trial includes an open label portion for adults with type 1 diabetes up to 15 years since diagnosis.
  • It has been exciting to participate in this study and explore this new pathway for the benefit of our patients.

New Research from Dario Demonstrates Ability to Deliver Improved Health Outcomes with Integrated Solution for Members Managing Weight and Blood Glucose with or without GLP-1 Medications

Retrieved on: 
Mardi, mars 12, 2024

NEW YORK, March 12, 2024 /PRNewswire/ -- DarioHealth Corp. (Nasdaq: DRIO) (the "Company"), a leader in the global digital therapeutics (DTx) market, announced today two new clinical studies presented at the 17th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) 2024, held March 6 – 9 in Florence, Italy.

Key Points: 
  • Dario's cardiometabolic solution integrates digital tools, connected devices and intelligent technologies to deliver a personalized and integrated experience to help drive better outcomes through effective behavior change.
  • Today, members can utilize the Dario solution with or without a GLP-1 medication and receive support tailored to their unique need.
  • The first study presented at ATTD analyzed the data of members engaged in Dario's cardiometabolic solution to manage pre-diabetes, a condition that requires weight loss and regulation of A1c.
  • A second Dario study presented at ATTD evaluated the effectiveness of Dario's digital health solution as a means to improve flu vaccine awareness and rates.

INHALE-3 Study’s Initial Meal Challenge Results Comparing Afrezza® Head-To-Head With Multiple Daily Injections (MDI) and Insulin Pumps

Retrieved on: 
Lundi, mars 11, 2024

INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care.

Key Points: 
  • INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care.
  • “In this large, randomized trial utilizing more appropriate dose conversion, we are excited to see meal challenge results support the safety and efficacy of inhaled insulin from the start.”
    INHALE-3 is a 17-week randomized controlled trial with a 13-week extension.
  • Subjects utilizing inhaled insulin received a higher initial conversion dose than in the current label.
  • For the meal challenge, the inhaled insulin group took an inhaled insulin dose immediately prior to a standardized meal (a 240 calorie nutritional shake) whereas those using usual care used RAA 5-15 minutes prior to the meal.

Structure Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Highlights

Retrieved on: 
Vendredi, mars 8, 2024

SAN FRANCISCO, March 08, 2024 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic and cardiopulmonary diseases, today reported financial results for the fourth quarter and full year ended December 31, 2023, and highlighted recent corporate achievements.

Key Points: 
  • “In 2023 we demonstrated clear proof-of-concept with our lead GLP-1 receptor agonist, GSBR-1290, for obesity and type 2 diabetes.
  • This study is fully enrolled and data are expected in the latter half of the second quarter of 2024.
  • The Company plans to initiate a global Phase 2b obesity study of GSBR-1290 in the fourth quarter of 2024.
  • Net Loss: Net loss for the fourth quarter of 2023 totaled $24.5, with non-cash stock-based compensation expense of $2.1 million, compared to $11.9 million for the fourth quarter of 2022 with non-cash stock-based compensation expense of $0.6 million.

MannKind Announces New Clinical Data From Inhale-3 Study to be Presented by Dr. Irl B. Hirsch at ATTD on March 8

Retrieved on: 
Mardi, mars 5, 2024

INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care.

Key Points: 
  • INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care.
  • “With ABC and this trial, we used a higher initial conversion dose for inhaled insulin than in our current label.
  • In the ABC study, this conversion dose produced significantly lowered post-prandial glucose levels that peaked 30 minutes sooner than standard of care.
  • More information on the study is available at: ClinicalTrials.gov(NCT05904743) .

Better Therapeutics Announces an Innovative Partnership with the American College of Lifestyle Medicine to Expand Access to AspyreRx Across 1,400 Federally Qualified Health Centers

Retrieved on: 
Mardi, mars 5, 2024

Through this partnership, Better Therapeutics is committed to making one million prescriptions of its U.S. Food and Drug Administration (FDA)-authorized product, AspyreRx , available to support underserved patients through 1,400 Federally Qualified Health Center (FQHC) organizations.

Key Points: 
  • Through this partnership, Better Therapeutics is committed to making one million prescriptions of its U.S. Food and Drug Administration (FDA)-authorized product, AspyreRx , available to support underserved patients through 1,400 Federally Qualified Health Center (FQHC) organizations.
  • This underscores the urgent need for evidence-based interventions to ensure equitable access to high-quality care for all.
  • The Lifestyle Medicine National Training Initiative (NTI) is an extension of ACLM’s $24.1 million commitment to the 2022 White House Conference on Hunger, Health, and Nutrition .
  • Better Therapeutics and ACLM are seeking additional partners and funding to support the implementation and maximize the initiative’s impact.

Stelo by Dexcom First Glucose Biosensor to be Cleared by FDA as Over-the-Counter

Retrieved on: 
Mardi, mars 5, 2024

DexCom, Inc. (NASDAQ:DXCM), the global leader in real-time continuous glucose monitoring for people with diabetes, announced today that the FDA has cleared Stelo by Dexcom – the first glucose biosensor that doesn’t require a prescription.

Key Points: 
  • DexCom, Inc. (NASDAQ:DXCM), the global leader in real-time continuous glucose monitoring for people with diabetes, announced today that the FDA has cleared Stelo by Dexcom – the first glucose biosensor that doesn’t require a prescription.
  • There are approximately 25 million people in the U.S. living with Type 2 diabetes who do not use insulin and who can benefit from continuous glucose monitoring (CGM) technology.
  • Today, Dexcom G7 is available for them with a prescription.
  • To learn more about Stelo and do a benefits check to see if you’re eligible to get started now with Dexcom G7, visit https://www.dexcom.com/en-us/stelo .

Perry Health Named to the New York Digital Health 100 by Digital Health New York (DHNY)

Retrieved on: 
Mercredi, février 21, 2024

NEW YORK, Feb. 21, 2024 /PRNewswire/ -- Perry Health has been honored to be named in the 2024 New York Digital Health 100 ( DH100 ), a distinction that showcases the top digital health startups in New York.

Key Points: 
  • NEW YORK, Feb. 21, 2024 /PRNewswire/ -- Perry Health has been honored to be named in the 2024 New York Digital Health 100 ( DH100 ), a distinction that showcases the top digital health startups in New York.
  • The annual list is published by Digital Health New York ( DHNY ) in partnership with the New York Healthcare Innovation Report, providing valuable insights into investment trends, opportunities, and challenges within the digital health sector.
  • Perry Health, built on principles of inclusivity and equitable healthcare access, advocates for timely, personalized care for every patient, irrespective of their location or socioeconomic status.
  • "We're thrilled to be named to the New York Digital Health 100," stated Pan Chaudhury, CEO of Perry Health.